Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000873426p
Ethics application status
Submitted, not yet approved
Date submitted
10/07/2025
Date registered
12/08/2025
Date last updated
12/08/2025
Date data sharing statement initially provided
12/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
MeAsuring the beNefits of TRAuma sensitive yoga for survivors of sexual violence in adulthood (MANTRA Study)
Scientific title
A randomised non-inferiority trial of trauma-sensitive yoga compared to group cognitive processing therapy to reduce Complex Post-Traumatic Stress Disorder symptoms for survivors of sexual violence in adulthood (The MANTRA Study)
Secondary ID [1] 314719 0
UoM CT ID: 32664
Universal Trial Number (UTN)
Trial acronym
MANTRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual violence in adulthood 337921 0
Complex post-traumatic stress disorder 337967 0
Condition category
Condition code
Mental Health 334272 334272 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MANTRA intervention is a trauma-sensitive Kundalini yoga (TSY) program consisting of 12 x weekly face-to-face sessions, each lasting around 75 minutes with up to 15 participants. The intervention will be delivered by an experienced teacher using a standard manual. The group TSY focuses on restoring normal physical and psychological functioning through postures and exercises, breathing techniques, relaxation, meditation/mindfulness and movement. It promotes connection between body and mind through performing kriyas (movement, poses, breath, mantra). An attendance form will be completed and the total number of sessions attended by each participant will be recorded. Participants who miss a session without notice will be contacted by a group facilitator and their absence followed up, with encouragement to return next session.

Intervention code [1] 331347 0
Treatment: Other
Comparator / control treatment
The comparator is a manualised 12-week face-to-face group Cognitive Processing Therapy (CPT) program delivered by two trained clinicians over 90 minutes, representing gold-standard trauma-focused treatment for sexual violence-related Complex post-traumatic stress disorder. Each group will have up to 12 participants and will be facilitated by two CPT trained clinicians. CPT addresses safety, trust, control, self-esteem, and intimacy, aiming for a balanced, adaptive response to trauma. Although individual CPT tends to perform slightly better than group CPT, the group model is a) more feasible and b) better matched with the TSY intervention. CPT sessions will focus on recognising thoughts and feelings; remembering the SV; identifying ‘stuck points’, challenging unhelpful thought patterns; and working through issues of trust, safety, power, control and self-esteem. An attendance form will be completed and the total number of sessions attended by each participant will be recorded. Participants who miss a session without notice will be contacted by a group facilitator and their absence followed up, with encouragement to return next session.
Control group
Active

Outcomes
Primary outcome [1] 341933 0
Complex Post Traumatic Stress Disorder symptoms
Timepoint [1] 341933 0
Baseline and 6 months post-completion of intervention
Secondary outcome [1] 449054 0
Post Traumatic Stress symptoms
Timepoint [1] 449054 0
Baseline and immediately post completion of 12-week intervention
Secondary outcome [2] 449055 0
Mood disturbance
Timepoint [2] 449055 0
Baseline and 6 months post-completion of intervention
Secondary outcome [3] 449056 0
Self-compassion
Timepoint [3] 449056 0
Baseline and immediately post completion of 12-week intervention
Secondary outcome [4] 449057 0
Cost-effectiveness
Timepoint [4] 449057 0
Baseline and 6 months post completion of intervention

Eligibility
Key inclusion criteria
To be eligible for the MANTRA study, prospective participants (who may be of any gender) need to:
1. be 18 years or older
2. have had a non-consensual sexual experience >6 months ago (since age 18)
3. screen positive for Complex posttraumatic stress disorder (CPTSD) on the International Trauma Questionnaire (ITQ) Disturbances in Self-Organisation (DSO) sub-scale
4. self-assess as safe from current intimate partner violence
5. have English comprehension sufficient to participate
6. in the past 6 months, not engaged in regular practice of CPT (>6 sessions), yoga (1 or more sessions/week) or similar mind/body practice (1 or more sessions/week). People currently on a waitlist for these therapies will also be excluded.
7. not have an active substance dependence in the previous 6 months that impacted on their ability to perform daily tasks
8. not have had a psychiatric hospital admission or attempted suicide in the previous 6 months
9. plan to reside in Victoria for the next 12 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not applicable

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed as it will be done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible survivors who have provided informed consent and completed baseline measures will be randomly assigned with a 1:1 ratio to the intervention or comparison arm. The random allocation sequence will be computer-generated by the trial statistician, not involved the execution of the trial. Permuted block of random size will be used to ensure that the number of participants is balanced between the two study arms. The block sizes will not be disclosed until the participant recruitment target sample size has been reached.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
MANTRA is a non-inferiority trial. We require 370 eligible survivors (185 per group) at baseline to test with 80% power if the intervention is non-inferior to CPT for the primary outcome, allowing for 0.7 correlation between the baseline and 6-month follow-up measures and 30% attrition at 6 months based on other yoga trials. We will conclude that TSY is non-inferior if the lower limit of the 95% confidence interval (equivalent for one tailed significance level of 2.5%) around the between-group difference in the mean change of the International Trauma Questionnaire score at 6 months post-intervention from baseline lies above -3 points (given a standard deviation of 12). The non-inferiority margin of 3 points (0.25SD) is considered the largest clinically acceptable loss of effect when comparing intervention and control groups.

Participant characteristics and baseline measures will be summarised by each groups. Primary analysis will use an intention-to-treat approach where survivors will be analysed in their allocated study group, and data collected on individuals irrespective of intervention completion. We will use linear regression to estimate between-group mean change in CPTSD score at 6-months from baseline adjusting for baseline CPTSD score, reported with 95% confidence interval and p-value. Sensitivity analysis will adjust for pre-specified confounders (e.g. social support, child abuse). Similar regression analyses will be used for secondary continuous outcomes which will be described in detail in a statistical analysis plan (SAP). The SAP will also describe the methods for handling of missing data and non-adherence to the intervention; and supplementary analyses, including sensitivity analysis, mediator and moderator analyses, and other pre-specified exploratory analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2025
Actual
Date of last participant enrolment
Anticipated
15/06/2027
Actual
Date of last data collection
Anticipated
29/02/2028
Actual
Sample size
Target
370
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319274 0
Government body
Name [1] 319274 0
National Health and Medical Research Council
Country [1] 319274 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 321766 0
None
Name [1] 321766 0
Address [1] 321766 0
Country [1] 321766 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317849 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 317849 0
Ethics committee country [1] 317849 0
Australia
Date submitted for ethics approval [1] 317849 0
16/05/2025
Approval date [1] 317849 0
Ethics approval number [1] 317849 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142350 0
Prof Laura Tarzia
Address 142350 0
Department of General Practice and Primary Care, University of Melbourne, Cnr Grattan Street & Royal Parade, University of Melbourne VIC 3010
Country 142350 0
Australia
Phone 142350 0
+61 3 8344 4018
Fax 142350 0
Email 142350 0
[email protected]
Contact person for public queries
Name 142351 0
Elizabeth McLindon
Address 142351 0
Department of General Practice and Primary Care, University of Melbourne, Cnr Grattan Street & Royal Parade VIC 3010
Country 142351 0
Australia
Phone 142351 0
+61 3 8344 4102
Fax 142351 0
Email 142351 0
[email protected]
Contact person for scientific queries
Name 142352 0
Elizabeth McLindon
Address 142352 0
Department of General Practice and Primary Care, University of Melbourne, Cnr Grattan Street & Royal Parade, VIC 3010
Country 142352 0
Australia
Phone 142352 0
+61 3 8344 4102
Fax 142352 0
Email 142352 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.